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Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction (STIFFMAP)

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ClinicalTrials.gov Identifier: NCT02459626
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, University of Leipzig

Brief Summary:
StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

Condition or disease Intervention/treatment
Heart Failure With Normal Ejection Fraction Other: Diagnostic P-V-loops and MRI

Detailed Description:

Heart Failure with preserved ejection fraction (HFpEF) and diastolic dysfunction is a growing medical challenge. To date almost every second patient with heart failure has a preserved ejection fraction and recent data show that outcomes in these patients are as bad as in those with reduced ejection fraction. In clinical routine the diagnosis of HFpEF is complicated by indirect assessment of diastolic function. Mechanistically the diastolic dysfunction is among others believed to be caused by the development of diffuse myocardial fibrosis with an increase of extracellular matrix.

Direct assessment of the intrinsic diastolic function and stiffness of the ventricle can be obtained by pressure-volume-curve tracings through a conductance catheter. Although this offers the benefit of assessing load-dependent and load-independent parameters of diastolic function as well as information on contractility and ventricular-arterial coupling, the use of this technique is limited by its invasiveness in daily care.

Newer MRI techniques have made it possible to quantify not only local fibrosis but also diffuse fibrosis (i.e. T1-Mapping) and determine extracellular volumes.

Moreover, the role of right ventricular function is in HFpEF is not well defined.

Aim of the current study is therefore to evaluate the role of MRI in assessing cardiac fibrosis in the context of impaired LV diastolic function in HFpEF patients, as well as to evaluate the role of systolic and diastolic right ventricular functional impairment in this patient cohort.


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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Non-invasive Assessment of Cardiac Fibrosis by MRI Derived T1-Mapping and Ventricular Intrinsic Diastolic Function by Pressure-volume-analysis in Patients With Heart Failure With Preserved Ejection Fraction
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
HFpEF and servere diastolic dysfuntion
Left ventricular ejection fraction (LV-EF) > 50%, echocardiographic criteria for diastolic dysfunction, New York Heart Association classification (NYHA)=>2, Diagnostic P-V-loops and MRI
Other: Diagnostic P-V-loops and MRI
Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function

HFpEF no servere diastolic dysfuntion
LV-EF > 50%, no echocardiographic criteria for diastolic dysfunction, NYHA=>2, Diagnostic P-V-loops and MRI
Other: Diagnostic P-V-loops and MRI
Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function

No HF or diastolic dysfunction
LV-EF > 50%, no diastolic dysfunction, no heart failure, Diagnostic P-V-loops and MRI
Other: Diagnostic P-V-loops and MRI
Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function




Primary Outcome Measures :
  1. Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops) [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. LV stiffness constant (ß) between groups [ Time Frame: Baseline ]
  2. Time constant of LV-relaxation (Ƭ) between groups [ Time Frame: Baseline ]
  3. Change in endiastolic pressure volume relation (EDPVR) under excercise between groups [ Time Frame: Baseline ]
  4. Right Ventricular Endsystolic Elastance Slope [ Time Frame: Baseline ]
  5. Right Ventricular Endsystolic Stiffness Constant [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recruitment of consequtive patients from our general cardiology clinic that present with signs of heart failure or suspected CAD with indication for invasive assessment and fullfill eligibility criteria.
Criteria

Inclusion Criteria:

  • LV-EF > 50%
  • Indication for invasive cardiac catheterization

Exclusion Criteria:

  • know CAD or CAD in Angiography (stenoses > 50%)
  • acute coronary syndromes
  • Cerebral ischemia within the last year
  • contraindications for MRI
  • more than mild valvular disease
  • Constrictive pericarditis, restrictive Cardiomyopathy, pericardial effusion
  • pregnancy
  • enrolment in other study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459626


Locations
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Germany
Heart Center of the University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Philipp Lurz, PhD University Heart Center Leipzig

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philipp Lurz, PD Dr. Philipp Lurz, PhD, University of Leipzig
ClinicalTrials.gov Identifier: NCT02459626     History of Changes
Other Study ID Numbers: 1.02
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases